Ceftazidime Injection
» Ceftazidime Injection is a sterile isoosmotic solution of Ceftazidime in Water for Injection. It contains one or more suitable buffers and a tonicity-adjusting agent. It contains not less than 90.0 percent and not more than 120.0 percent of the labeled amount of C22H22N6O7S2.
Packaging and storage— Preserve in Containers for Injections as described under Injections 1. Maintain in the frozen state.
Labeling— It meets the requirements for Labeling under Injections 1. The label states that it is to be thawed just prior to use, describes conditions for proper storage of the resultant solution, and directs that the solution is not to be refrozen.
Identification— The chromatogram of the Assay preparation obtained as directed in the Assay exhibits a major peak for ceftazidime, the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparation obtained as directed in the Assay.
Pyrogen 151 It meets the requirements, the test dose being a volume of undiluted Injection providing 80 mg of ceftazidime per kg.
Sterility 71 It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pH 791: between 5.0 and 7.5.
Particulate matter 788: meets the requirements for small-volume injections.
pH 7 Buffer, Mobile phase, Standard preparation, Resolution solution, and Chromatographic system— Proceed as directed in the Assay under Ceftazidime.
Assay preparation— Allow a container of the Injection to thaw, and mix the solution. Transfer an accurately measured volume of the Injection, equivalent to about 50 mg of ceftazidime, to a 50-mL volumetric flask, dilute with pH 7 buffer to volume, and mix. Transfer 5.0 mL of this solution to a second 50-mL volumetric flask, dilute with water to volume, and mix.
Procedure— Proceed as directed for Procedure in the Assay under Ceftazidime. Calculate the quantity, in mg, of C22H22N6O7S2 in each mL of the Injection taken by the formula:
0.5(C / V)(rU / rS)
in which C is the concentration, in µg per mL, of ceftazidime (C22H22N6O7S2) in the Standard preparation; V is the volume, in mL, of Injection taken; and rU and rS are the ceftazidime peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
(MDANT05) Monograph Development-Antibiotics
Reference Standards Lili Wang, Technical Services Scientist
151 Radhakrishna S Tirumalai, Ph.D.
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(MSA05) Microbiology and Sterility Assurance
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Senior Scientist
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USP32–NF27 Page 1858
Pharmacopeial Forum: Volume No. 34(4) Page 907
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.